Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088100
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HEPARIN SODIUM HEPARIN SODIUM 5,000 UNITS/ML INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/28/1983 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/2013 SUPPL-41 Labeling-Container/Carton Labels

Label is not available on this site.

05/06/2013 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

05/01/2013 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

12/30/2009 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

05/06/2009 SUPPL-30 Labeling

Label is not available on this site.

10/23/2008 SUPPL-27 Labeling

Label is not available on this site.

02/14/2001 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/09/1998 SUPPL-13 Labeling

Label is not available on this site.

12/11/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/02/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/06/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/21/1992 SUPPL-7 Labeling

Label is not available on this site.

12/01/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/15/1991 SUPPL-5 Labeling

Label is not available on this site.

06/01/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/11/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/08/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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